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A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S*BIO
ClinicalTrials.gov Identifier:
NCT01263899
First received: December 16, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes

December 16, 2010
April 19, 2012
December 2010
February 2012   (final data collection date for primary outcome measure)
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: No ]
Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Same as current
Complete list of historical versions of study NCT01263899 on ClinicalTrials.gov Archive Site
  • Assess durability of response [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: No ]
    To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.
  • Assess number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Indolent Lymphoma
Drug: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
Experimental: SB1518
Intervention: Drug: SB1518
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histologically documented diagnosis of one of the following lymphoid malignancies:
  • Hodgkin Lymphoma;
  • Mantle Cell Lymphoma;
  • Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma);
  • Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant;
  • Able to understand and willing to sign the informed consent form.

Exclusion Criteria:

  • Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;
  • History of or active Central Nervous System (CNS) malignancy;
  • Active graft-versus-host disease (GVHD);
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01263899
SB1518-2010-005
No
S*BIO
S*BIO
Not Provided
Principal Investigator: Anas Younes, MD MD Anderson Cancer Center at University of Texas, Houston
Principal Investigator: Jonathan Friedberg, MD University of Rochester James P. Wilmot Cancer Center
Principal Investigator: Peter Martin, MD Weill Medical College of Cornell University
Principal Investigator: Julie Vose, MD University of Nebraska
Principal Investigator: Richard Klasa, MD British Columbia Cancer Center - Vancouver Centre
S*BIO
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP